Dynarex Corporation recalled 2,592 bottles of WeCare Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers and healthcare providers must stop using the ointment immediately and seek guidance.
cGMP deviations
Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter
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The recalled product is WeCare Zinc Oxide Ointment, net weight 15 oz (425 g). It was manufactured for Dynarex Corporation, located at 11 Dynarex Drive, Middletown, NY 10941. The affected lot numbers are A062434 and A062449, with expiration dates of June 27, 2027, and July 27, 2027.
The recall results from deviations in current Good Manufacturing Practices (cGMP). These deviations can lead to potential quality issues, impacting the safety and efficacy of the product.
No specific incidents or injuries have been reported in connection with this recall. The risk level is classified as high due to the potential implications of cGMP deviations.
Consumers should stop using WeCare Zinc Oxide Ointment immediately. Contact Blossom Pharmaceuticals or a healthcare provider for further guidance on the recall.
For more information, consumers can visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0205-2026 or contact Blossom Pharmaceuticals.
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